Device class
Class II
Regulation 880.5725
Total clearances
5
2020-03-12 → 2023-06-15
Classification details
Medical specialty
General Hospital
Regulation number
880.5725
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
B. Braun Melsugen AG |
1 |
0 |
2020-03-12 |
|
Welldoc, Inc.
|
1 |
0 |
2020-04-07 |
|
Gilero, LLC |
1 |
0 |
2023-06-15 |
|
Elite Biomedical Solutions |
1 |
0 |
2022-04-29 |
|
Chengdu Shifeng Medical Technology Co., Ltd. |
1 |
0 |
2021-03-26 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| E1520 |
HCPCS
|
Heparin infusion pump for hemodialysis ✓ CMS-verified description |
High
|
Standard HCPCS code for infusion pump accessory supplies |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2023-06-15 |
K230718 |
Gilero, LLC
|
UTC 3mL Medication Cartridge |
| 2022-04-29 |
K220695 |
Elite Biomedical Solutions
|
Elite Biomedical Solutions Dose Request Cord |
| 2021-03-26 |
K201634 |
Chengdu Shifeng Medical Technology Co., Ltd.
|
RG 3ml Medication Cartridge |
| 2020-04-07 |
K193654 |
Welldoc, Inc.
|
BlueStar Rx |
| 2020-03-12 |
K191910 |
B. Braun Melsugen AG
|
SpaceStation MRI |